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Biosimilars Forum disappointed in FDA guidance
March 2017
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WASHINGTON, D.C.—In response to the FDA’s final guidance on nonproprietary naming of biological products, the Biosimilars Forum recently noted that “While we are pleased that the FDA has finalized the guidance, we are disappointed in their decision to apply meaningless suffixes in the naming convention for biological drugs. Non-meaningful suffixes will certainly be more difficult for physicians and patients to recall than meaningful suffixes. Additionally, they will likely lessen the ability to carefully track the identity of the biologic drug administered to patients, thereby contrary to the stated purpose of having a suffix to enhance pharmacovigilance.
 
“The introduction of biosimilars in the U.S. can help expand access to high-quality treatment options for clinicians and patients as well as reduce costs to families, caregivers, payers and the healthcare systems. Biosimilars are a key free-market solution to lowering drug costs, and we will continue to work with the FDA to advance these products to the marketplace.”

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